Substance AddictionPhase 3NCT00225316
Maternal Acupuncture for Substance Abuse
A Phase 3 study testing Acupuncture in people with Substance Addiction, run by University of British Columbia at 1 site in Canada.
Trial summary
To determine the efficacy of daily maternal acupuncture treatments in reducing the frequency and severity of neonatal abstinence syndrome among infants born to substance-using women.. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Addiction
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Aug 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women admitted to the chemical dependency unit at BC Women's Hospital, Vancouver, B.C.
Who cannot join
- Women who neither read nor write English
- Having a pacemaker or any other electrical implants
- Bleeding disorder or on anti-coagulants
- Conditions putting someone at particular risk for infection including damaged heart valves or prior heart valve surgery, history of myocardiopathy, diabetes requiring insulin, history of knee or hip replacements, immunosuppressive drug therapy, open wounds.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Maternal Acupuncture for Chemically Dependent Pregnant Women Reduce the Severity of Neonatal Abstinence Syndrome? - A Randomized Controlled Trial
To determine the efficacy of daily maternal acupuncture treatments in reducing the frequency and severity of neonatal abstinence syndrome among infants born to substance-using women..
Read the detailed description
Potential study subjects will be recruited from the Chemical Dependency Unit by a trial coordinator. After obtaining written informed consent, the coordinator will take a sequentially numbered opaque envelope from a box on the unit. This envelope will contain a card indicating the treatment group to which the woman is allocated. Women participating in the treatment group of our study will have access to a quiet room furnished with comfortable reclining chairs. The acupuncturist will swab the ears with alcohol and insert sterile, disposable needles. Following the treatment, which is 45-minutes in length, participants will remove the needles themselves and place them in protective sharps boxes. A sham acupuncture procedure will not be used. Chinese traditional medicine does not include the concept of a placebo. Those who argue that auricular acupuncture stimulates the vagus nerve, which innervates the ear concha state that needles placed anywhere in the concha should produce the same effects. 58 Studies utilizing sham procedures have failed to show a difference between the control and active experimental conditions.
In this unit, morphine is prescribed for the neonate by pediatricians (11 in total) if there is a constellation of symptoms unresponsive to environmental control including: 1) convulsions, 2) inconsolability or crying continuously for 3 hours, 3) persistent tremors or jitteriness when undisturbed, 4) continuous central nervous system irritability including hyperactive Moro reflex, tremors, jitteriness, increased muscle tone and unprovoked muscle jerks, 5) persistent vomiting or projectile vomiting over a 12 hour period; or 6) explosive diarrhea for 2-3 consecutive episodes. Additional clinical signs such as tachycardia, tachypnea, watery stools, fever, or weight loss > 10% may justify use of morphine after consideration of differential diagnoses. Morphine 1mg/ml is started at a rate of 0.03 mg/kg/dose every 3 hours. The dose is reviewed daily and titrated based on daily weights and ongoing symptoms.
- Conditions
- Substance Addiction
- Being tested
- Acupuncture
- Keywords
- RCT, intervention study, addiction, substance use, pregnancy
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of newborn morphine treatment
Secondary outcomes (1)
Gestational age at birth, rates of intrauterine growth restriction, days to regain birthweight, rates of admission to a level II or level III nursery and length of stay, and rates of apprehension of the infant by the Ministry of Children and Families
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AddictionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Patricia Janssen, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225316
- Sponsor's protocol ID
- W05-0041
- Other IDs
- 04-2985
- Status last verified
- May 2011
- First submitted
- 21 Sep 2005
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Maternal Acupuncture for Chemically Dependent Pregnant Women Reduce the Severity of Neonatal Abstinence Syndrome? - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00225316
- Acronym / sponsor ID
- W05-0041
- Conditions
- Substance Addiction
- Keywords
- RCT, intervention study, addiction, substance use, pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy of daily maternal acupuncture treatments in reducing the frequency and severity of neonatal abstinence syndrome among infants born to substance-using women..
Detailed description
Potential study subjects will be recruited from the Chemical Dependency Unit by a trial coordinator. After obtaining written informed consent, the coordinator will take a sequentially numbered opaque envelope from a box on the unit. This envelope will contain a card indicating the treatment group to which the woman is allocated. Women participating in the treatment group of our study will have access to a quiet room furnished with comfortable reclining chairs. The acupuncturist will swab the ears with alcohol and insert sterile, disposable needles. Following the treatment, which is 45-minutes in length, participants will remove the needles themselves and place them in protective sharps boxes. A sham acupuncture procedure will not be used. Chinese traditional medicine does not include the concept of a placebo. Those who argue that auricular acupuncture stimulates the vagus nerve, which innervates the ear concha state that needles placed anywhere in the concha should produce the same effects. 58 Studies utilizing sham procedures have failed to show a difference between the control and active experimental conditions.
In this unit, morphine is prescribed for the neonate by pediatricians (11 in total) if there is a constellation of symptoms unresponsive to environmental control including: 1) convulsions, 2) inconsolability or crying continuously for 3 hours, 3) persistent tremors or jitteriness when undisturbed, 4) continuous central nervous system irritability including hyperactive Moro reflex, tremors, jitteriness, increased muscle tone and unprovoked muscle jerks, 5) persistent vomiting or projectile vomiting over a 12 hour period; or 6) explosive diarrhea for 2-3 consecutive episodes. Additional clinical signs such as tachycardia, tachypnea, watery stools, fever, or weight loss > 10% may justify use of morphine after consideration of differential diagnoses. Morphine 1mg/ml is started at a rate of 0.03 mg/kg/dose every 3 hours. The dose is reviewed daily and titrated based on daily weights and ongoing symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women admitted to the chemical dependency unit at BC Women's Hospital, Vancouver, B.C.
Key exclusion criteria (4 listed)
- Women who neither read nor write English
- Having a pacemaker or any other electrical implants
- Bleeding disorder or on anti-coagulants
- Conditions putting someone at particular risk for infection including damaged heart valves or prior heart valve surgery, history of myocardiopathy, diabetes requiring insulin, history of knee or hip replacements, immunosuppressive drug therapy, open wounds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureSee Detailed Description. | Procedure or surgery | – |
Primary outcome
Days of newborn morphine treatment
1 secondary outcome
Gestational age at birth, rates of intrauterine growth restriction, days to regain birthweight, rates of admission to a level II or level III nursery and length of stay, and rates of apprehension of the infant by the Ministry of Children and Families
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Patricia Janssen principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture in people with Substance Addiction, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of newborn morphine treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.